Activity, Work Impairment Scores Improved With 3D Regimens in HCV GT1

SAN FRANCISCO, CA—Interferon-free ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin (the 3D + RBV or 3D regimens) showed a more favorable Work Productivity and Activity Impairment (WPAI) profile in treatment-naïve, non-cirrhotic, HCV GT1-infected patients, compared to telaprevir + peginterferon/ribavirin (TPV + pegIFN/RBV), reported researchers at The Liver Meeting® 2015.

"Interferon-containing regimens for chronic hepatitis C can further worsen the WPAI of patients," explained Yan Liu, MD, PhD, from AbbVie, North Chicago, IL, and coauthors. They analyzed the WPAI of patients who participated in the Phase 3b MALACHITE-I study (n=311).

Patients with GT1a infection were randomized 2:1 to receive 12 weeks of 3D + RBV or 12 weeks of TPV + pegIFN/RBV followed by 12–36 more weeks of pegIFN/RBV. Patients with GT1b infection were randomized 2:2: to 3D + RBV, 3D, or TPV + pegIFN/RBV. Researchers measured baseline and change from baseline during treatment and post-treatment periods using the WPAI hepatitis C module (WPAI-HCV). Baseline characteristics were similar across groups, noted Dr. Liu.

"Mean baseline total work productivity impairment and total activity impairment scores for Week 12 and PT-w12 analyses varied from 2.5 to 9.1 and 9.3 to 13.4 across treatment groups," Dr. Liu and coauthors reported.

For total work productivity impairment, "smaller additional impairments were observed at Week 12 with 3D + RBV in GT1b (P=0.004) and GT1a (P<0.001) vs. TPV + pegIFN/RBV," they reported. "There was an improvement over baseline in GT1b patients receiving 3D (P<0.001)."

Interferon-based treatment of HCV infection has historically been associated with impaired work productivity and activity, and quality of life, the authors noted. "This remains true in the 'first-generation DAA era,' where patients received interferon and ribavirin along with newer agents, such as telaprevir."

"However, this is not the case with the ombitasvir/paritaprevir/ritonavir + dasabuvir regimen, whether or not it is given with ribavirin," they concluded. "In addition to the increased efficacy of the all-oral regimens, we are now able to demonstrate their increased tolerability (especially in terms of the patient's ability to maintain all of their usual activities while on HCV therapy), even if ribavirin is used as part of the therapeutic intervention."